Eligibility of patients for sacubitril/valsartan in a secondary care heart failure service

The first-in-class drug sacubitril/valsartan (Entresto^TM) has been recommended for use in the UK by the National Institute for Health and Care Excellence (NICE) following evidence from the PARADIGM-HF (Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality and morbidity in Heart Failure) trial. To qualify, patients should have severe left ventricular dysfunction (ejection fraction ≤35%), New York Heart Association (NYHA) grade II–IV symptomatic heart failure, and be on a stable dose of angiotensin-converting enzyme inhibitor (ACEi) or angiotensin-receptor blocker (ARB). We evaluated all patients seen in our nurse-led heart failure clinics over a six-month period to assess suitability for sacubitril/valsartan and the resulting cost implication. 

Of 553 patients seen, more than two thirds (69%) were unsuitable, of whom most had an ejection fraction greater than 35%. Other reasons included hypotension, NYHA class I, renal dysfunction, intolerance of ACEi/ARB and compliance concerns. There were 49 patients who died within nine months of the study period end. Of these, most (84%) were unsuitable for sacubitril/valsartan. Compared with current local use of ACEi and ARB, switching the 174 suitable patients to sacubitril/valsartan would cost £171,816 per year.

In our real-world experience, 31–37% of patients attending a specialist nurse-led heart failure clinic may be suitable for sacubitril/valsartan therapy. While the clinical benefits of this treatment are well proven and a recent NICE technology assessment has demonstrated cost-effectiveness, the medication has significant upfront cost implications for healthcare commissioners.

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